Malaysia Extends Biocon Biologics' Insulin Supply Contract for Six Additional Months
• The Malaysian Health Ministry has extended its insulin supply contract with Biocon Biologics for an additional six months, from April 29 to October 28, 2025, continuing a partnership that has lasted nearly a decade.
• The extension follows the original three-year contract valued at $90 million awarded in 2022 for Biocon's recombinant human insulin brand Insugen, which is manufactured in Malaysia and distributed through local partner Duopharma Marketing.
• Biocon's insulin products are available to patients across all Ministry of Health hospitals, district health offices, and health clinics throughout Malaysia, supporting the country's healthcare infrastructure.
Biocon Plans ₹4,500 Crore QIP to Reduce Debt and Increase Biologics Stake
• Biocon chairperson Kiran Mazumdar-Shaw announced plans for a ₹4,500 crore qualified institutional placement to convert structured venture debt into equity, aiming to strengthen the company's balance sheet.
• The fundraising initiative comes after Biocon Biologics' $3.3 billion acquisition of Viatris's global biosimilars business in 2022, which left the company with approximately $1.2 billion in acquisition-related debt.
• Despite generating 25% EBITDA on over $1 billion in sales, Biocon's profitability has been significantly impacted by debt provisioning, with the company now considering merging Biologics with the parent company instead of pursuing an IPO.
Biocon Announces $150 Million Capital Expenditure Plan Amid Strong Q4 Performance
• Biocon plans to invest $150 million in capital expenditure over the next two years, with $100 million allocated to biologics expansion in Malaysia and $50 million to generics.
• The biopharmaceutical company reported a 153% surge in Q4 net profit to Rs 344 crore, driven by strong growth in generics and steady progress in biosimilars.
• Biocon is expanding its product portfolio with recent launches of lenalidomide and dasatinib in the US, liraglutide in the UK, and plans to launch bevacizumab and insulin aspart in the US market.
Shionogi to Acquire Japan Tobacco's Pharmaceutical Subsidiaries for $1.1 Billion
• Shionogi & Co. plans to acquire Japan Tobacco's pharmaceutical subsidiaries Torii Pharmaceutical and Akros Pharma for ¥160 billion ($1.1 billion) to strengthen its global R&D capabilities.
• The acquisition, negotiated since early 2024, will proceed through a tender offer beginning June 18 with a share price of ¥6,350 to acquire at least 11.89% of the minority stake.
• This strategic move represents significant consolidation in the Japanese pharmaceutical sector and expands Shionogi's market presence amid increasing global competition.
Biocon Biologics Receives Positive CHMP Opinions for Denosumab Biosimilars in Europe
• The Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Biocon Biologics' denosumab biosimilars, Vevzuo and Denosumab BBL, for bone health indications in Europe.
• The positive opinions follow comprehensive data reviews demonstrating comparability with the reference product in pharmacokinetic, safety, efficacy, and immunogenicity profiles.
• The European Commission will now review these recommendations before granting marketing authorizations, after which detailed information on approved indications will be published in official EU documentation.
Biocon Biologics Secures Settlement with Regeneron to Launch Aflibercept Biosimilar in US by 2026
• Biocon Biologics has reached a settlement agreement with Regeneron allowing the launch of Yesafili, an interchangeable biosimilar to aflibercept, in the US by the second half of 2026 or earlier under certain circumstances.
• The agreement resolves pending legal disputes, including an appeal at the US Court of Appeals for the Federal Circuit and litigation in the Northern District of West Virginia, clearing regulatory hurdles for market entry.
• FDA-approved in May 2024, Yesafili will target multiple ophthalmic conditions including neovascular AMD, macular edema due to retinal vein occlusion, diabetic macular edema, and myopic choroidal neovascularization.
FDA Approves Biocon Biologics' Bevacizumab Biosimilar JOBEVNE for Multiple Cancer Indications
• Biocon Biologics has received U.S. FDA approval for JOBEVNE (bevacizumab-nwgd), a biosimilar to Avastin, expanding its oncology portfolio to include a seventh FDA-approved biosimilar.
• JOBEVNE, a VEGF inhibitor that restricts tumor blood supply, is indicated for multiple cancer types including metastatic colorectal cancer, non-small cell lung cancer, glioblastoma, and several others.
• The approval follows comprehensive comparative studies confirming JOBEVNE's similarity to Avastin, with U.S. bevacizumab sales reaching approximately $2 billion in 2023, representing a significant market opportunity.
Lilly's Mounjaro Demonstrates Superior Efficacy in Head-to-Head Trials Against Diabetes Competitors
• Eli Lilly's Mounjaro (tirzepatide) has shown superior efficacy in reducing HbA1c levels and body weight compared to Novo Nordisk's Ozempic in clinical trials, offering new hope for the 35 million Americans with type 2 diabetes.
• As the first dual-action medication that stimulates both GLP-1 and GIP receptors, Mounjaro achieved mean HbA1c reductions of 1.7% to 2.4% across trials, with participants losing between 12-25 pounds depending on dosage.
• Recently launched in India following CDSCO approval, Mounjaro is now indicated for both chronic weight management in adults with obesity or overweight with comorbidities, and as an adjunct treatment for type 2 diabetes mellitus.
Hikma Pharmaceuticals Prepares to Launch Generic Versions of Ozempic and Wegovy
• Hikma Pharmaceuticals is in talks with global partners to develop generic versions of semaglutide, the active ingredient in Novo Nordisk's blockbuster weight loss drugs Ozempic and Wegovy.
• Patents for Novo Nordisk's semaglutide drugs will begin expiring in 2026 in markets including Canada, China, India, and Brazil, with other regions following between 2028 and 2032.
• Hikma's CEO Riad Mishlawi compared the impact of GLP-1 weight loss medications to penicillin, noting they address obesity-related comorbidities in a market potentially worth $80-140 billion.
Lupin Launches Generic Rivaroxaban in US Market Following FDA Approval
• Lupin has launched Rivaroxaban Tablets USP, 2.5 mg in the US market after receiving final approval from the FDA for its Abbreviated New Drug Application.
• The generic equivalent of Janssen's Xarelto® targets patients with coronary artery disease and peripheral artery disease, with estimated annual US sales of $446 million.
• This strategic launch strengthens Lupin's position in the high-value anticoagulant market, following the company's strong Q3 performance with a 38.8% increase in profit.
FDA Greenlights Amgen and Allergan's Herceptin Biosimilar Kanjinti Amid Patent Expiry
The FDA has approved Kanjinti (trastuzumab-anns), a biosimilar version of Roche's blockbuster breast cancer drug Herceptin, developed by Amgen and Allergan. The approval comes as Herceptin's main US patent expires, potentially opening the market to competition in a space where the reference drug generated $2.9 billion in US sales last year.
FDA Grants Priority Review to CUTX-101 for Menkes Disease, Offering Hope for Rare Pediatric Condition
• The FDA has accepted Sentynl Therapeutics' NDA for CUTX-101, granting priority review for the treatment of Menkes disease, a rare genetic disorder.
• Clinical trials of CUTX-101 demonstrated an almost 80% reduction in mortality risk compared to untreated patients, significantly improving overall survival.
• CUTX-101 has been granted multiple designations, including Breakthrough Therapy and Orphan Drug, highlighting its potential to address a critical unmet need.
• Cyprium Therapeutics is eligible to receive up to $129 million in milestone payments and royalties, retaining ownership of a potential Priority Review Voucher.
FDA Approves Tevimbra-Chemotherapy Combination for First-Line Treatment of Advanced Esophageal Squamous Cell Carcinoma
• The FDA has approved BeiGene's Tevimbra (tislelizumab-jsgr) in combination with platinum-containing chemotherapy for first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma whose tumors express PD-L1.
• In the pivotal RATIONALE-306 trial, patients treated with Tevimbra plus chemotherapy demonstrated a median overall survival of 16.8 months compared to 9.6 months with chemotherapy alone, representing a 34% reduction in risk of death.
• This marks BeiGene's third FDA approval in less than a year, following previous approvals for Tevimbra in second-line ESCC and first-line gastric/gastroesophageal junction cancers, highlighting the company's expanding oncology portfolio.
FDA Approves Steqeyma and Yesintek: Expanding Biosimilar Options for Stelara
• The FDA has approved Steqeyma (ustekinumab-stba) and Yesintek (ustekinumab-kfce) as biosimilars to Stelara, offering new options for patients with autoimmune and inflammatory conditions.
• Steqeyma and Yesintek are approved for plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis, mirroring Stelara's indications.
• These approvals are expected to increase market competition and reduce treatment costs, with launches anticipated in early 2025 following licensing agreements.
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